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The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial

Study acronym: POPCORN
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 1 of 9 sitesv8
  2. Study sites: 6 to 9 Collaborator revisedv7 Show 1 more changeShow less
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 1 of 6 sitesv6
  4. Primary completion date: Jul 31, 2027 to Jul 31, 2028 Study sites: 5 to 6 · Completion date: Apr 30, 2028 to Apr 30, 2029 · Start date: Aug 1, 2023 to Aug 21, 2023 · 2 morev5 Show 5 more changesShow less
    • Study sites: 5 to 6
    • Completion date: Apr 30, 2028 to Apr 30, 2029
    • Start date: Aug 1, 2023 to Aug 21, 2023
    • Study description expanded, about 15 words
    • Study title shortened, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 30, 2027 to Jul 31, 2027 · Completion date: Dec 31, 2027 to Apr 30, 2028 · Start date changed from estimate of Jul 31, 2023 to Aug 1, 2023 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Jul 30, 2027 to Jul 31, 2027
    • Completion date: Dec 31, 2027 to Apr 30, 2028
    • Start date changed from estimate of Jul 31, 2023 to Aug 1, 2023
    • Site details revised at 5 of 5 sites
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jul 17, 2023 to Jul 31, 2023v3
  2. Start date: May 1, 2023 to Jul 17, 2023 Primary completion date: Apr 1, 2027 to Jul 30, 2027 · Eligibility criteria expanded, about 33 words · Site details revised at 1 of 5 sitesv2 Show 3 more changesShow less
    • Primary completion date: Apr 1, 2027 to Jul 30, 2027
    • Eligibility criteria expanded, about 33 words
    • Site details revised at 1 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Heart disease remains the leading cause of death in Veterans. Inflammation in the arteries of the heart may increase the risk of cardiac death. Patients with heart disease undergoing major surgery are at increased risk of complications after surgery, including heart attack, stroke, and death. The proposed research seeks to better understand the role of inflammation in the damage to the heart and blood vessels after major surgery. This research also seeks to identify the potential beneficial role of a safe medication, colchicine, which has direct effects on inflammatory cells and has been used in the treatment of inflammatory diseases for more than 2000 years, on reducing the rate of complications after surgery. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of heart injury, stroke, or death after major surgery.
Trial Details
NCT Number NCT05618353
Lead Sponsor VA Office of Research and Development
Collaborators: NYU Langone Health
Conditions Coronary Artery Disease
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov